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510(k) K913803

INTRALUMINAL ARTERY STRIPPER by Omni-Tract Surgical, Div. Minn. Scientific, Inc. — Product Code DWX

K913803 is an FDA 510(k) premarket notification submitted by Omni-Tract Surgical, Div. Minn. Scientific, Inc. for the device "INTRALUMINAL ARTERY STRIPPER". The FDA issued a decision of Substantially Equivalent on April 24, 1992. The device falls under product code DWX (Stripper, Artery, Intraluminal), a Class II device regulated under 21 CFR 870.4875. Omni-Tract Surgical, Div. Minn. Scientific, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1992
Date Received
August 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stripper, Artery, Intraluminal
Device Class
Class II
Regulation Number
870.4875
Review Panel
CV
Submission Type

Other clearances by Omni-Tract Surgical, Div. Minn. Scientific, Inc.

  • K001339 — MRI FASTSYSTEM RETRACTOR SYSTEM (May 17, 2000)
  • K992583 — MASS (MICRO-ACCESS SPINE SYSTEM) (October 29, 1999)
  • K950214 — ABDOMINAL WALL RETRACTOR (February 6, 1995)

Other clearances for product code DWX

  • K121415 — MOLLRING MULTITASC (September 5, 2012)
  • K032105 — ENDOHELIX ENDARTERECTOMY DEVICE (October 30, 2003)
  • K020925 — CARBODISSECTING ENDOSCOPE (April 29, 2003)
  • K003719 — VASCULAR ARCHITECTS PERISCOPE DEVICE (February 28, 2001)
  • K950813 — MOLLRING CUTTER (July 25, 1995)
  • K933498 — EXTERNAL VEIN STRIPPER (March 23, 1994)
  • K911099 — MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE (June 25, 1991)
  • K904944 — TRANSLUMINAL ENDARTERECTOMY DEVICE (December 17, 1990)
  • K895878 — OLYMPUS VALVULOTOME W/DETACHABLE TIP (January 2, 1990)
  • K894496 — OLYMPUS VALVULOTOME W/FIXED TIP (October 12, 1989)

FDA data resources